RECRUITING

ACE2016 in Adult Subjects With Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

ACE2016 is an off-the-shelf, allogeneic gamma delta T (gdT) cell therapy derived from healthy donors, that is under investigation for the treatment of Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR). The ACE2016-001 study is an open-label, Phase I, first-in-human (FIH) study that aims to evaluate the safety and tolerability, persistency, pharmacodynamics and efficacy of ACE2016 in patients with Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR).

Official Title

A Phase 1 Multicenter Study Evaluating the Safety and Efficacy of ACE2016, an Allogeneic Anti-EGFR Conjugated Gamma Delta T Cell (gdT) Therapy in Adult Subjects With Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR)

Quick Facts

Study Start:2024-08-22
Study Completion:2027-03-27
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06415487

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Locally advanced unresectable or metastatic solid tumors that have failed at least two lines of therapy (one of which must be targeted therapy)
  2. * At least one measurable lesion as defined by RECIST v1.1 criteria
  3. * Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
  4. * Adequate hematologic and renal, hepatic and cardiac function
  5. * Oxygen saturation via pulse oximeter ≥92% at rest on room air
  1. * Prior treatment with a genetically modified cell therapy product targeting EGFR
  2. * History of allogeneic transplantation
  3. * Subjects with active CNS metastases
  4. * History or presence of clinically relevant Central Nervous System (CNS) disorder (e.g. epilepsy)
  5. * Clinically significant active infection
  6. * Human Immunodeficiency Virus (HIV) infection, active hepatitis B infection, or hepatitis C infection.
  7. * History of malignancies with the exception of certain treated malignancies with no evidence of disease.
  8. * Primary immunodeficiency disorder
  9. * Pregnant or lactating female
  10. * Any medical, psychological, familial, or sociological conditions that, in the opinion of the Investigator or Sponsor Medical Monitor, would impair the ability of the subject to receive study treatment or comply with study requirements, including understanding and rendering of informed consent

Contacts and Locations

Study Contact

Stephanie Chien
CONTACT
+1 415 366 7822
clinical@acepodiabio.com

Study Locations (Sites)

University of California San Diego
San Diego, California, 92093
United States
SCRI Denver Drug Development Unit
Denver, Colorado, 80218
United States
Sarah Cannon Research Institute (SCRI) Oncology Partners
Nashville, Tennessee, 37203
United States
Texas Oncology
Dallas, Texas, 75246
United States

Collaborators and Investigators

Sponsor: Acepodia Biotech, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-22
Study Completion Date2027-03-27

Study Record Updates

Study Start Date2024-08-22
Study Completion Date2027-03-27

Terms related to this study

Additional Relevant MeSH Terms

  • Locally Advanced Solid Tumor
  • Metastatic Solid Tumor